Conference: what’s next for the EMA?

The European Medicines Agency (EMA) and the European Commission have held a joint conference to discuss the outcome of Ernst & Young’s recent year-long evaluation of the Agency and how to prepare for future challenges.

Outcomes of the evaluation, which were published in April, found that the current system is providing “complete, clear and highly-valued opinions within tight regulatory deadlines and allows the contribution of the best available experts in Europe, while ensuring the impartiality of their assessments.”

However, E&Y also cautioned that the EMA’s two main opinion-making committees – the Committee for Medicinal Products for Human Use (CHMP) and its veterinary drugs counterpart (CVMP) - are “overwhelmed with work” and that their agendas could “hardly be extended.” The whole system is fast reaching maximum capacity, it warned.

The conference - which included around 150 partners and stakeholders from the European Commission, European Union (EU) national competent authorities, patients and healthcare professional associations and the pharmaceutical industry associations - focused on the architecture of the EMA’s scientific forums, ways to assure long-term availability of scientific resources of the network and the Agency’s coordinating role. There was also an exchange of views about the EMA’s funding.

Nils Behrndt, who is the deputy Head of Cabinet for EU Health Commissioner John Dalli, said that the E&Y report had shown the EMA and the whole of the European medicines network to have been a success story for Europe so far. However, he added: “the system will have to adapt to take on all the new responsibilities in the pipeline. This conference is the beginning of a process of reflection to make sure that the EMA is equipped for the future.”

The Network model - consisting of the national authorities, the Commission and the Agency - has worked very well for the first 15 years, added EMA executive director Thomas Lonngren, but he noted that: “as the scientific, political and societal parameters of our environment are changing, we need to look at the architecture of our ‘house’ again to make sure it is fit for purpose. We are opening up this process of reflection to our stakeholders to get the broadest possible consensus on the direction the Agency is taking in the future.”

Some of the key questions of this reflection process include: - how can the EMA deal effectively with the increasing globalisation of the pharmaceutical industry? - is it fit for new scientific developments, such as advanced therapies and personalised medicines? - how can regulators respond to requests from patients and healthcare professionals for more participation and transparency? And - how can the particular requirements of veterinary medicines best be accommodated?

The Agency and the Commission will prepare a joint conference report detailing the ideas and proposals made during the conference, some of which are already included in the Agency's Road Map to 2015.